Browsing by Author "Matovu, Brian"

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    Regulation and standards of medical devices in Uganda
    (East African Health Scientific Conference, 2018) Matovu, Brian
    The term “medical devices” includes everything from highly sophisticated computerized medical equipment down to simple wooden tongue depressors (WHO, 2003). The regulation of medical devices is a vast and rapidly evolving field that is often complicated by legal technicalities. Recently it has been observed that improvements on biomedical devices and systems used in diagnosis and treatment of illnesses have progressed parallel to the technological developments. However, the tendency to calibrate, regulate and set standards for health equipment and other biomedical devices is still a puzzle in developing countries like Uganda. Although the consciousness and importance of calibration have reached to a remarkable point in some other national sectors such as industry and trade in the past twenty years, the issue of calibration, regulation and setting of standards has started to be discussed in the past five years for the biomedical devices which are directly related to the health of human beings mainly in East Africa (Rugera, McNerney et al. 2014). The Global Harmonization Task Force and the international medical devices regulator forum (IMDRF) have proposed the following harmonized definition for medical devices which may be of help in setting standards and regulations ie a Medical device means any instrument, apparatus, implement, machine, appliance, implant, in vitroreagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purposes of: diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation of or compensation for an injury, investigation, replacement, modification, or support of the anatomy or of a physiological process, supporting or sustaining life, control of conception, disinfection of medical devices, providing information for medical purposes by means of in vitro examination of specimens derived from the human body and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.
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    Systems and processes for regulation of investigational medical devices in Uganda
    (Frontiers in Medical Technology, 2023-01-23) Mpaata, Charles Norman; Matovu, Brian; Takuwa, Mercy; Wolters, Maria; Ssekitoleko, Robert T.
    In many parts of the world, medical devices and the processes of their development are tightly regulated. However, the current regulatory landscape in Uganda like other developing countries is weak and poorly defined, which creates significant barriers to innovation, clinical evaluation, and translation of medical devices. To evaluate current knowledge, systems and infrastructure for medical devices regulation and innovation in Uganda. A mixed methods study design using the methods triangulation strategy was employed in this study. Data of equal weight were collected sequentially. First, a digital structured questionnaire was sent out to innovators to establish individual knowledge and experience with medical device innovation and regulation. Then, a single focus group discussion involving both medical device innovators and regulators to collect data about the current regulatory practices for medical devices in Uganda. Univariate and bivariate analysis was done for the quantitative data to summarize results in graphs and tables. Qualitative data was analyzed using thematic analysis. Ethical review and approval were obtained from the Makerere University School of Biomedical Sciences, Research and Ethics Committee, and the Uganda National Council for Science and Technology. A total of 47 innovators responded to the questionnaire. 14 respondents were excluded since they were not medical device innovators. Majority (76%) of individuals had been innovators for more than a year, held a bachelor's degree with a background in Engineering and applied sciences, and worked in an academic research institute. 22 of the 33 medical device innovators had stopped working on their innovations and had stalled at the proof-of-concept stage. Insufficient funding, inadequate technical expertise and confusing regulatory landscape were major challenges to innovation. The two themes that emerged from the discussion were “developing standards for medical devices regulation” and “implementation of regulations in practical processes”. Legal limitations, lengthy processes, and low demand were identified as challenges to developing medical device regulations. Conclusions: Efforts have been taken by government to create a pathway for medical device innovations to be translated to the market. More work needs to be done to coordinate efforts among stakeholders to build effective medical device regulations in Uganda.
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    The role of medical equipment in the spread of nosocomial infections: a crosssectional study in four tertiary public health facilities in Uganda
    (BMC Public Health, 2020) Ssekitoleko, Robert T.; Oshabaheebwa, Solomon; Munabi, Ian G.; Tusabe, Martha S.; Namayega, C.; Ngabirano, Beryl A.; Matovu, Brian; Mugaga, Julius; Reichert, William M.; Joloba, Moses L.
    With many medical equipment in hospitals coming in direct contact with healthcare workers, patients, technicians, cleaners and sometimes care givers, it is important to pay close attention to their capacity in harboring potentially harmful pathogens. The goal of this study was to assess the role that medical equipment may potentially play in hospital acquired infections in four public health facilities in Uganda. Methods A cross-sectional study was conducted from December 2017 to January 2018 in four public health facilities in Uganda. Each piece of equipment from the neonatal department, imaging department or operating theatre were swabbed at three distinct points: a location in contact with the patient, a location in contact with the user, and a remote location unlikely to be contacted by either the patient or the user. The swabs were analyzed for bacterial growth using standard microbiological methods. Seventeen bacterial isolates were randomly selected and tested for susceptibility/resistance to common antibiotics. The data collected analyzed in STATA version 14. Results A total of 192 locations on 65 equipment were swabbed, with 60.4% of these locations testing positive (116/192). Nearly nine of ten equipment (57/65) tested positive for contamination in at least one location, and two out of three equipment (67.7%) tested positive in two or more locations. Of the 116 contaminated locations 52.6% were positive for Bacillus Species, 14.7% were positive for coagulase negative staphylococcus, 12.9% (15/116) were positive for E. coli, while all other bacterial species had a pooled prevalence of 19.8%. Interestingly, 55% of the remote locations were contaminated compared to 66% of the user contacted locations and 60% of the patient contacted locations. Further, 5/17 samples were resistant to at least three of the classes of antibiotics tested including penicillin, glycylcycline, tetracycline, trimethoprim sulfamethoxazole and urinary anti-infectives. Conclusion These results provides strong support for strengthening overall disinfection/sterilization practices around medical equipment use in public health facilities in Uganda. There’s also need for further research to make a direct link to the bacterial isolates identified and cases of infections recorded among patients in similar settings.
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    Variation in Susceptibility of Eucalyptus Grandis and Selected Hybrid Clones to two Termite Species Macrotermes Bellicosus and M. Subhyalinus in Uganda
    (All Life, 2021) Nakabonge, Grace; Matovu, Brian
    The maximum productivity of plantation forestry and its role in climate change mitigation, adaptation and resilience cannot be met without proper management. Termites in the genus Macrotermes have been reported as a major challenge to Eucalyptus plantation forestry establishment. The current study evaluated the susceptibility of four Eucalyptus hybrid clones: GU 7, GC 796, GC 550 and GC 796/2, and E. grandis Hill ex Maid. to the most damaging Macrotermes bellicosus (Smeathman) and Macrotermes subhyalinus (Rambur) to identify tolerant material that can be planted in high incidence areas. The study involved exposure of moisture dry pieces of wood from E. grandis and the four hybrid clones to damage by M. bellicosus and M. subhyalinus. Results confirmed that M. bellicosus is the most aggressive. Results further revealed that E. grandis and GC 550 are the most susceptible whereas GC 796 is the most tolerant clone. The findings from the study will contribute to improved management of termites by planting tolerant material in high risk areas.